Authorising Generics and Biosimilars in Switzerland
Short answer
A generic is authorised under Art. 12 TPA by reference to an originator product authorised in Switzerland; the decisive factor is proof of bioequivalence. Biosimilars follow their own, considerably larger programme involving analytical, preclinical and clinical comparability. Both are only possible once first applicant protection has expired.
What requirements apply to a generic?
The reference product must be authorised in Switzerland, first applicant protection must have expired, and bioequivalence must be demonstrated in a study against the Swiss reference product. Where the study was conducted against a foreign product, proof is needed that it is identical to the Swiss product.
- Identical active substance, same quantity, same dosage form as the reference product.
- Bioequivalence study under the applicable bioequivalence guidelines, generally a 90 percent confidence interval within 80.00 to 125.00 percent.
- A complete quality module with its own specifications and stability data.
- Medicinal product information that corresponds in content to that of the reference product.
- Expired first applicant protection under Art. 11a and 11b TPA.
How long does first applicant protection last?
For a medicinal product with a new active substance, first applicant protection runs for ten years from authorisation. For a new indication, a new route of administration or a new dosage it is three years. Separate, longer periods apply for paediatric development programmes and for medicinal products for rare diseases.
| Subject | Basis | Duration |
|---|---|---|
| New active substance | Art. 11a TPA | 10 years |
| New indication, dosage, route of administration | Art. 11b TPA | 3 years |
| Paediatric investigation plan, conditions fulfilled | Art. 11b TPA | 6-month extension |
| Medicinal products for rare diseases | Art. 11b TPA | 10 years |
| Patent protection | Patent Act, independent of the TPA | 20 years from filing, extendable |
What is different for biosimilars?
A biosimilar is not identical to the reference product but highly similar to it. Demonstration proceeds in steps: extensive analytical and functional comparability first, then preclinical and clinical comparative data, usually including immunogenicity. A bioequivalence study alone is never sufficient.
- Define the reference product authorised in Switzerland and procure batches for comparison.
- Demonstrate analytical comparability across critical quality attributes, including glycosylation and aggregation.
- Generate functional assays and preclinical comparative data.
- Show clinical comparability in the most sensitive population, with immunogenicity data.
- Justify extrapolation to further indications of the reference product.
- Submit a risk management plan with traceability down to batch level.
What follows authorisation for market access?
For reimbursement, an application follows to the FOPH for inclusion in the Specialities List. There, generics are subject to price differentials from the originator product, staggered by market volume. Swissmedic's authorisation decision says nothing about reimbursement.
Frequently asked questions
Can I submit with an EU bioequivalence study?
Yes, if the reference product used in the study is identical to the product authorised in Switzerland. This identity must be substantiated, for example through composition, manufacturer and batch data.
How long does authorising a generic take?
The regulatory time matches the standard procedure, usually with one round of questions in practice. Plan for ten to fifteen months to the decision.
Does a biosimilar need its own clinical study?
Generally, yes. The scope depends on the analytical comparability; the more convincing that is, the smaller the clinical programme can be.
What is a co-marketing medicinal product, as opposed to a generic?
A co-marketing medicinal product is identical to an already authorised base product and is marketed only under a different name. It is authorised through the notification procedure and needs no bioequivalence study of its own.
Does first applicant protection run from authorisation or from market access?
From the authorisation of the first applicant's product in Switzerland, not from inclusion in the Specialities List.
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